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Feb. 27, 2015, 9:59 AM
- Biogen Idec (BIIB -0.5%) and collaboration partner Swedish Orphan Biovitrum AB announce positive top-line results from a Phase 3 trial evaluating Alprolix (Coagulation Factor IX [Recombinant], Fc Fusion Protein) in children under age 12 with severe hemophilia B.
- Medical professionals recommend prophylactic treatment in children with severe hemophilia in order to manage and/or prevent bleeding episodes, but frequent administration schedules can be burdensome for patients and caregivers. Alprolix is administered once every 7 - 10 days for routine prophylaxis (prevention).
- In the study, children treated with Alprolix experienced an overall median annualized bleeding rate (ABR) of 1.97, while the median ABR for spontaneous joint bleeds was zero. About one third of the participants had no bleeding episodes at all. Overall, 91.7% of bleeding episodes were controlled by one or two infusions of Alprolix. None of the patients produced inhibitors (antibodies) to Alprolix in the study, which was the most significant potential complication of treatment.
- The European Medicines Agency requires the inclusion of pediatric study data in the initial Marketing Authorization Application (MAA) for a new hemophilia treatment. Interim data were used in the U.S. New Drug Application (NDA).
- Alprolix is the only approved hemophilia B therapy with prolonged circulation in the body. The FDA cleared it in March of last year. It generated $25.3M and $40.3M in sales for Biogen in Q3 and Q4, respectively.
- Related tickers: (BAX +0.3%)(OPK -0.8%)(SGMO -1.9%)(ALNY -1.9%)(ONCE +3%)(PFE -0.2%)(SHPG -1.6%)
Feb. 13, 2015, 9:21 AM
- Alnylam Pharmaceuticals (ALNY +0.5%) Q4 results: Revenues: $24M (+122.2%); R&D Expense: $55.6M (+73.2%); SG&A: $14.2M (+71.1%); Operating Loss: ($45.7M) (-54.4%); Net Loss: ($21.4M) (+34.0%); Loss Per Share: ($0.28) (+45.1%).
- FY2014 results: Revenues: $50.6M (+7.2%); R&D Expense: $190.2M (+68.3%); SG&A: $44.5M (+63.6%); Operating Loss: ($405M) (-336.0%); Net Loss: ($360.4M) (-304.0%); Loss Per Share: ($4.85) (-234.5%); Quick Assets: $881.9M (+151.6%).
- 2015 Guidance: Cash, Cash Equivalents and Total Marketable Securities: > $1.2B.
Feb. 12, 2015, 4:03 PM
- Alnylam Pharmaceuticals (NASDAQ:ALNY): Q4 EPS of -$0.28 beats by $0.32.
- Revenue of $24M (+121.2% Y/Y) beats by $10.91M.
Feb. 11, 2015, 5:35 PM
Jan. 30, 2015, 12:31 PM
- Opko Health (OPK +3.5%) submits an Investigational New Drug Application (IND) to the FDA for clearance to commence a Phase 2a study evaluating its long-acting Orphan Drug-designated coagulation Factor VIIa (Factor VIIa-CTP) for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to Factor VII or Factor IX.
- Currently, Factor VIIa therapy is administered intravenously which requires multiple infusions, due to its short half-life, to treat a bleeding episode.
- The longer duration of action of Opko's Factor VIIa-CTP is based on the naturally occurring peptide, C-terminal peptide, of the beta chain of human chorionic gonadotropin (hCG).
- Opko acquired the rights to the product when it bought Prolor Biotech.
- Previously: Opko completes its acquisition of Prolor Biotech (Aug. 29, 2013)
- Related tickers: (BAX +0.4%)(SGMO +0.6%)(ALNY +0.5%)(BIIB +11.4%)(OTCPK:BAYRY -1.4%)
Jan. 21, 2015, 7:29 AM
- Alnylam (NASDAQ:ALNY) prices its public offering of 4,736,842 shares of common stock at $95 per share. Underwriters over-allotment is an additional 710,526 shares. Closing date is January 26.
Jan. 20, 2015, 7:19 AM
- Alnylam (NASDAQ:ALNY) initiates a $450M public offering of common stock. Underwriters over-allotment is an additional 15% of the number of shares offered. Pricing has yet to be announced.
Dec. 23, 2014, 12:45 PM
Dec. 15, 2014, 7:54 AM
- The Q-50 Index houses those companies next-eligible for inclusion into the Nasdaq 100 (NASDAQ:QQQ). Amid the Nasdaq 100's annual changes which added and dropped three from the index, the Q-50's quarterly re-ranking adds and drops eleven.
- Added: Ainylam Pharma (NASDAQ:ALNY), Expedia (NASDAQ:EXPE), F5 Networks (NASDAQ:FFIV), JD.com (NASDAQ:JD), MercadoLibre (NASDAQ:MELI), Maxim Integrated (NASDAQ:MXIM), Old Dominion Freight Line (NASDAQ:ODFL), Shire (NASDAQ:SHPG), Splunk (NASDAQ:SPLK), Stratasys (NASDAQ:SSYS), United Therapeutics (NASDAQ:UTHR).
- Dropped: Avis Budget (NASDAQ:CAR), Cree (NASDAQ:CREE), First Solar (NASDAQ:FSLR), Golar LNG (NASDAQ:GLNG), Methanex (NASDAQ:MEOH), Melco Crown (NASDAQ:MPEL), Nuance (NASDAQ:NUAN), SolarCity (NASDAQ:SCTY). Also dropped are the three Nasdaq 100 additions: American Airlines, Lam Research, and Electronic Arts.
- Previously: Who's in, who's out in annual change to Nasdaq 100 (Dec. 13, 2014)
Dec. 11, 2014, 9:06 AM
- Alnylam Pharmaceuticals (NASDAQ:ALNY) earns a $10M milestone payment from The Medicines Company (NASDAQ:MDCO) by initiating a Phase 1 trial evaluating the safety and tolerability of Alnylam's cholesterol-lowering product candidate ALN-PCSsc in up to 76 volunteers with elevated baseline LDL-C. The U.K.-based study will be conducted in two stages: a single ascending dose and multiple doses. Initial data from the trial should be available by mid-2015.
- ALN-PCSsc is a PCSK9 inhibitor that is delivered via subcutaneous injection. Based on preclinical studies, it has the potential for a once-monthly or once-quarterly dose regimen. In non-human primate studies, the administration of ALN-PCSsc resulted in PCSK9 knockdown of up to 92% and lowering of LDL-C up to 77% without the co-administration of statins.
Dec. 9, 2014, 10:30 AM
- In a modest cohort of patients in a Phase 1 trial assessing Alnylam's (ALNY -2.2%) ALN-AT3, hemophilia subjects (n=4) receiving a once-weekly dose for three weeks of the antithrombin-targeting RNAi therapeutic demonstrated up to a 57% knockdown of antithrombin (AT), an endogenous anti-coagulant.
- In a cohort of healthy volunteers (n=4), the effects of a single dose of ALN-AT3 lasted for ~60 days.
- These are the first clinical data reported for the company's Enhanced Stabilization Chemistry (ESC)-GaINAc conjugate technology.
- EVP and CMO Akshay Vaishnaw, M.D., says, "...these data provide preliminary evidence for a high level of potency for RNAi therapeutics in humans with the improved pharmacologic properties for our ESC-GaINAc conjugate delivery technology. As supported by data we presented earlier this year, this improved potency appears to be due to the increased stabilization chemistry employed with our ESC platform as well as an attenuated nuclease environment in human cells."
- The results were presented at the American Society of Hematology meeting in San Francisco.
Nov. 14, 2014, 7:41 AM
- In a pilot Phase 2 study, Alnylam's (NASDAQ:ALNY) RNAi therapeutic, revusiran, demonstrated a mean maximum knockdown of 87.2% (+/- 9.1%) of serum transthyretin (TTR) in patients with TTR cardiac amyloidosis. The maximum knockdown observed was 98.2%.
- There were similar knockdown effects toward the wild type and mutant TTR protein within V122I patients, the most common genotype associated with inherited forms of TTR cardiac amyloidosis.
- Revusiran utilizes the company's proprietary GaINAc-conjugate delivery platform that enables a subcutaneous delivery of RNAi therapeutics with a wide therapeutic index.
- Alnylam will present the data this weekend at the American Heart Association meeting in Chicago.
Nov. 7, 2014, 5:35 PM
Nov. 5, 2014, 4:19 PM
- Alnylam Pharmaceuticals (NASDAQ:ALNY): Q3 EPS of -$0.58 beats by $0.05.
- Revenue of $10.97M (+22.0% Y/Y) beats by $2.04M.
- Shares +2.4%.
Nov. 5, 2014, 12:52 PM
- Alnylam (ALNY -0.5%) completes the enrollment of 26 patients in its Phase 2 study of revusiran (ALN-TTRsc) for the treatment of transthyretin (TTR) cardiac amyloidosis. Each subject received a five-week course of treatment.
- The Phase 2 open-label extension study is now open for enrollment. The trial will assess the safety and tolerability of long-term dosing of revusiran for up to two years. The company plans to report clinical data about once per year with the initial report expected in 2015.
- A Phase 3 trial evaluating revusiran in TTR cardiac amyloidosis is on track to start later this year.
Nov. 4, 2014, 5:35 PM
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